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Clinical Trial Associate

3+ years
Not Disclosed
10 Jan. 3, 2025
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Trial Associate (CTA)
Location: Lexington, United States
Job Category: Clinical Development

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About the Department:

At Novo Nordisk, our East Coast Global Development Hub in Lexington, MA and Plainsboro, NJ is home to cutting-edge life science innovation. We support programs from early research through late-stage clinical development, building a collaborative R&D community focused on multiple therapeutic areas and innovative modalities. Our East Coast hub combines biotech agility with the resources and stability of a large pharmaceutical company, ensuring we are developing new medicines to improve the lives of patients. If you’re ready to be part of this mission and make a difference, we want to hear from you.


The Position:

We are seeking an organized, detail-oriented Clinical Trial Associate (CTA) to support the execution of clinical trials. As a key member of the clinical development team, the CTA will assist in the overall management of clinical studies, from planning to closeout, ensuring trials are conducted in compliance with Good Clinical Practice (GCP) and regulatory requirements.


Key Responsibilities:

Study Management & Documentation:

  • Assist with managing clinical trials, ensuring effective execution and timely closeout of outsourced studies.
  • Collaborate with Clinical Project Managers (CPMs) in site management activities, such as reviewing monitoring reports, tracking site visits, and maintaining communication with monitors and sites.
  • Help prepare both external and internal study documentation to ensure compliance with GCP, regulatory guidelines, and the study protocol.
  • Create and distribute study materials and communications to KOLs, CROs, and other external vendors.

Study Tracking & Reporting:

  • Organize and maintain study tracking files and ensure the submission of up-to-date documentation to the Trial Master File.
  • Maintain global study site documentation in compliance with project timelines.
  • Support planning and preparation for investigator meetings, potentially providing on-site support.

Financial & Operational Support:

  • Assist with budget and invoice management to ensure financial tracking aligns with project activities.

Physical Requirements:

  • 10-20% overnight travel may be required for site visits and other study-related activities.

Qualifications:

Education & Experience:

  • Bachelor’s degree in a science or healthcare-related discipline.
  • Minimum of 3 years of experience supporting clinical studies within a pharmaceutical, biotechnology company, or CRO environment is preferred.

Skills & Knowledge:

  • Working knowledge of ICH GCP regulations and clinical protocols.
  • Strong interpersonal, organizational, and multi-tasking skills.
  • Proven analytical and problem-solving abilities, with a consistent sense of urgency and attention to detail.

Why Join Novo Nordisk:

At Novo Nordisk, we believe it is no longer enough to be the best company in the world. We strive to be the best company for the world, and we know this can only happen through a diverse workforce. We are committed to fostering an inclusive culture that celebrates our employees’ unique perspectives and backgrounds. Together, we’re life-changing.